Supervises and coordinates the staff and activities of designated studies. Interprets protocols, makes recommendations for program enhancement initiatives and maintains industry, FDA, and granting agency relationships. Adheres to and assists in the training of research staff on Good Clinical Practice, and regulatory and grant agency requirements. Supervises staff, ensures the safety and comfort of patients, and interfaces with related departments.
- Promotes Clinical Research department goals by selecting, motivating, and training capable team members.
- Leads the activities of assigned Clinical Research team members by communicating and providing guidance toward achieving department objectives.
- Supervises, hires, trains, disciplines and evaluates the performance of staff.
- Ensures performance appraisals are completed in a timely fashion.
- Maintains comprehensive study lists for departmental information; maintains cooperative relations with drug companies and other research centers for information on new research interests.
- Provides technical and functional expertise in the area of Research studies; recommends appropriate implementation plan; monitors study routine to ensure progress of studies and reports to PI; oversees compliance with regulatory and granting agencies.
- Responsible for coordination of the day-to-day activities of the designated study or group of studies in clinical based research; ensures appropriate screening and oversees recruitment of subjects, implements study procedures, supervises the scheduling of experiments and the collection, processing and analysis of data.
- Administers, scores and evaluates assessments as assigned and as related to study protocol; collects data, confers with PI and forwards results to sponsor (internal or external).
- Interfaces with the Office of Grants and Contracts (OGC) and Institutional Review Board (IRB).
- Organizes all phases of grant process for submission to funding agencies as necessary.
- Liaises with agencies, pharmaceutical companies, laboratories, and equipment and supply companies as needed.
- Makes recommendations for program enhancements, performance improvement, and best practices.
- Ensures the safety and comfort of patients being evaluated; supervises the scheduling of patients for clinical and biological evaluations; sets up educational workshops for patients and families; provides on-call coverage for patient concerns/complications.
- Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.
4-6 years of relevant experience and 0-2 years of leadership / management experience, required.